Clinical trial • Phase IV • Gastroenterology

SIMVASTATIN for Primary sclerosing cholangitis

Phase IV trial of SIMVASTATIN for Primary sclerosing cholangitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Primary sclerosing cholangitis
Trial Stage
Phase IV
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
13-02-2024
First CTIS Authorization Date
26-02-2024

Trial design

Randomised, placebo for simvastatin sandoz 40 mg tablets (placebo arm). simvastatin sandoz 40 mg film-coated tablet (active arm) - max daily dose 40 mg; dosing schedule not specified in the available data.-controlled Phase IV trial across 12 sites in Sweden.

Randomised
Yes
Comparator
Placebo for Simvastatin Sandoz 40 mg tablets (placebo arm). Simvastatin Sandoz 40 mg film-coated tablet (active arm) - max daily dose 40 mg; dosing schedule not specified in the available data.
Target Sample Size
560

Eligibility

Recruits 560 Vulnerable population selected. Participants must provide written consent ('Patient has given written consent to participate in the study'). Participants are adults (Men and women ≥18 years but ≤75 years). No details on assent procedures or consent for minors are provided in the available documentation..

Pregnancy Exclusion
Pregnancy and breastfeeding
Vulnerable Population
Vulnerable population selected. Participants must provide written consent ('Patient has given written consent to participate in the study'). Participants are adults (Men and women ≥18 years but ≤75 years). No details on assent procedures or consent for minors are provided in the available documentation.

Inclusion criteria

  • {"criterion_text":"- Patients with a cholangiographically verified PSC and/or liverbiopsy with and without IBD (patients with a present autoimmun hepatit and small duct PSC can be included)"}
  • {"criterion_text":"- Men and women ≥18 years but ≤75 years"}
  • {"criterion_text":"- Patient has given written consent to participate in the study"}
  • {"criterion_text":"- MR/MRCP within 4 months"}
  • {"criterion_text":"- Coloscopy within 24 months if the patient has a known IBD"}
  • {"criterion_text":"- Female of childbearing potential must agree to use a highly efficient method of contraception during the study participation."}

Exclusion criteria

  • {"criterion_text":"- Patients on waiting list for transplantation"}
  • {"criterion_text":"- Transplanted patients"}
  • {"criterion_text":"- Patients with severe liver failure ≥ Child B 9 points"}
  • {"criterion_text":"- Previous varices bleeding secondary to end stage liver disease"}
  • {"criterion_text":"- Previous cholangiocarcinoma"}
  • {"criterion_text":"- Patients with secondary sclerosing cholangitis"}
  • {"criterion_text":"- Patients who have been taking any statin medication during the last 3 months"}
  • {"criterion_text":"- Intolerance to statins"}
  • {"criterion_text":"- Pregnancy and breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of days from randomisation to death","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of days from randomisation to listing of liver transplantation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of days from randomisation to first variceal bleeding","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of days from randomization to diagnosis bile duct cancer, gall bladder cancer or hepatocellular cancer (diagnosed with characteristic x-ray (focal) or histological/cytological diagnosis).","definition_or_measurement_approach":"Diagnosis by characteristic imaging (focal on x-ray) or histological/cytological confirmation as specified in the endpoint text."}

Secondary endpoints

  • {"endpoint_text":"- Serumconcentrations of alkaline phosphatase","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Serumconcentration of bilirubin","definition_or_measurement_approach":""}
  • {"endpoint_text":"- MELD Score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Child Pugh Score","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Progress of cholangiographic image with MR","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Elastography","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Symptoms related to PSC (itching or bacterial colangitis requiring treatment, ascites, encephalopathy)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Dysplasia in the biliary tract or gall bladder","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Development of colon cancer or dysplasia","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
560
Recruitment Window Months
135
Consent Approach
Written informed consent required from participants ('Patient has given written consent to participate in the study'). Subject information and informed consent form documents (SIS and ICF SE) are present. Participants must be adults (≥18 years); no details on assent for minors or multilingual consent materials are provided in the available documentation.

Geography

Total Number Of Sites
12
Total Number Of Participants
560

Sweden

Earliest CTIS Part Ii Submission Date
19-01-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
721
Number Of Sites
12
Number Of Participants
560

Sites

Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Department of Gastroenterology
Contact Person Name
Nikolaus Papachrysos
Site Name
Skaraborg Hospital-Vastra Gotalandsregionen
Department Name
Department of gastroenterology
Contact Person Name
Gunnar Midhagen
Contact Person Email
gunnar.midhagen@vgregion.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Department of Gastroenterology
Contact Person Name
Emma Nilsson
Contact Person Email
emma.nilsson@skane.se
Site Name
Region Oestergoetland
Department Name
Department of Gastroenterology
Contact Person Name
Stergios Kechagias
Contact Person Email
stergios.kechagias@liu.se
Site Name
Region Vaermland
Department Name
Department of Gastroenterology
Contact Person Name
Petru-Cosmin Madar
Contact Person Email
petru.madar@regionvarmland.se
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen (Goteborg site)
Department Name
Department of Gastroenterology
Contact Person Name
Antonio Molarino
Contact Person Email
antonio.molinaro@wlab.gu.se
Site Name
Region Vaesterbotten
Department Name
Department of Gastroenterology
Contact Person Name
Mårten Werner
Site Name
Karolinska University Hospital
Department Name
Medical unit Inflammation and Ageing
Contact Person Name
Charlotte Hedin
Contact Person Email
charlotte.hedin@ki.se
Site Name
Uppsala University Hospital
Department Name
Department of Gastroenterology
Contact Person Name
Fredrik Rorsman
Contact Person Email
fredrik.rorsman@akademiska.se
Site Name
Karolinska University Hospital (Huddinge)
Department Name
Medical Unit Upper Abdominal
Contact Person Name
Annika Bergqvist
Contact Person Email
annika.bergquist@ki.se
Site Name
Danderyds Sjukhus AB
Department Name
Department of Gastroenterology
Contact Person Name
Anna Häggström
Site Name
Region Oerebro Laen
Department Name
Medical clinic
Contact Person Name
Nils Nyhlin
Contact Person Email
nils.nyhlin@orebroll.se

Sponsor

Primary sponsor

Full Name
Karolinska University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Simvastatin Sandoz 40 mg filmdragerade tabletter
Active Substance
SIMVASTATIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
Authorised (marketingAuthNumber: 17536, authorisationCountryCode: SE)
Starting Dose
40 mg
Dose Levels
40 mg
Maximum Dose
40 mg
Investigational Product Name
Placebo for Simvastatin Sandoz 40 mg tablets.
Modality
Other

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